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Comprehensive treatment of microvascular angina in overweight women - a randomized controlled pilot trial.

ABSTRACT: AIMS:Coronary microvascular dysfunction (CMD) carries a poor cardiovascular prognosis and may explain angina in women without obstructive coronary artery disease (CAD). Currently, no evidence-based treatment for CMD exists. We investigated whether reducing cardiovascular risk factors improves symptoms and microvascular function in women with non-endothelial dependent CMD and no obstructive CAD. METHODS:We randomized 62 women aged 40-75, with body mass index (BMI) >25 kg/m2, angina ?monthly, and coronary flow velocity reserve (CFVR) ?2.5 to a 24-week intervention comprising low energy diet, exercise training, and optimized treatment of hypertension, dyslipidemia and diabetes or to control. Patients were assessed before randomization and after 24 weeks. Primary outcomes were CFVR assessed by transthoracic Doppler stress-echocardiography and angina burden by Seattle Angina Questionnaire (SAQ). Secondary outcomes were exercise capacity, body composition, glycemic control, myocardial function, and anxiety and depression symptoms. RESULTS:Fifty-six participants (90%) completed the study. Median (IQR) age was 65.2 (57.1;70.7) years, BMI was 30.1 (28.4;32.7) kg/m2. The intervention resulted in relevant improvement in angina symptoms (9-21-point increase on SAQ-scales (all p<0.01)) but had no effect on CFVR (p = 0.468). Mean (CI) weight loss was 9.6 (7.80;11.48) kg, (p<0.0001). There was a significant mean (CI) decrease in depression symptoms = 1.16 (0.22;2.12), triglycerides = 0.52 (0.25;0.78) mmol/L, total cholesterol = 0.55 (0.12;0.98) mmol/L, and HbA1c in diabetics = 27.1 (1.60;52.6) mmol/mol but no effect on other secondary outcomes. CONCLUSION:A major weight loss and intensified risk factor control resulted in significantly improved angina burden but no improvement of coronary microvascular function among women with microvascular angina.

SUBMITTER: Bove KB

PROVIDER: S-EPMC7644075 | biostudies-literature | 2020

REPOSITORIES: biostudies-literature

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Comprehensive treatment of microvascular angina in overweight women - a randomized controlled pilot trial.

Bove Kira Bang KB Nilsson Malin M Pedersen Lene Rørholm LR Mikkelsen Nicolai N Suhrs Hannah Elena HE Astrup Arne A Prescott Eva E

PloS one 20201105 11

<h4>Aims</h4>Coronary microvascular dysfunction (CMD) carries a poor cardiovascular prognosis and may explain angina in women without obstructive coronary artery disease (CAD). Currently, no evidence-based treatment for CMD exists. We investigated whether reducing cardiovascular risk factors improves symptoms and microvascular function in women with non-endothelial dependent CMD and no obstructive CAD.<h4>Methods</h4>We randomized 62 women aged 40-75, with body mass index (BMI) >25 kg/m2, angina ...[more]

PMID: 33151955

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Project description:ImportanceThe role of the coronary venous circulation in regulating myocardial perfusion and its potential in treating microvascular angina is unexplored.ObjectiveTo evaluate whether an increase in coronary venous pressure modifies microvascular resistance in patients with microvascular angina.Design, setting, and participantsThis was a blinded, sham-controlled, crossover, randomized clinical trial that enrolled participants between November 2021 and January 2023. Participants for this physiology end point study were recruited from the Cardiology Center of the University of Medicine in Mainz, Germany. Patients with moderate/severe angina pectoris (Canadian Cardiovascular Society class 2-4) due to microvascular dysfunction (as defined by the thermodilution-based index of microvascular resistance >25 mm Hg × s). Exclusion criteria were epicardial coronary disease, second- and third-degree atrioventricular block, severe valvular heart disease, cardiomyopathy, and pulmonary or kidney disease.InterventionInflation of an undersized balloon placed in the cardiac coronary sinus (CS), hereafter referred to as balloon and the deflated balloon in the right atrium, referred to as sham. Measurements were performed at rest and during maximal coronary hyperemia. Both patients and final assessors were blinded to the randomization sequence.Main outcomes and measuresHemodynamic parameters, including aortic (Pa) and distal (Pd) coronary pressure, coronary sinus pressure (Pcs), right atrial pressure (Pra), and the mean transit time (inverse of blood flow [Tmn]), were measured.ResultsA total of 20 patients (median [IQR] age, 69 [64-75] years; 11 female [55.0%]) were included in the study. Two patients (10%) had diabetes, 6 (30%) had hypercholesterolemia, 15 (75%) had hypertension, and 3 (15%) were active smokers. The inflation of the CS balloon caused a significant increase in CS pressure at rest and during hyperemia (300% and 317% increase, respectively, compared with sham, both P < .001), a decrease in hyperemic distal coronary pressure (median [IQR], sham: 92 [80-100] mm Hg; balloon: 79 [75-93] mm Hg; P = .01) and mean transit time (sham: 0.39 [0.23-0.62] s; balloon: 0.26 [0.17-0.46] s; P = .008). As a result, CS occlusion led to a decrease in both resting coronary resistance (median [IQR], sham: 59 [37-87] mm Hg × s; balloon: 42 [31-67] mm Hg × s; P = .005) and the primary end point hyperemic coronary resistance (mean [IQR], sham: 31 [23-53] mm Hg × s; balloon: 14 [8-26] mm Hg × s; P < .001).Conclusion and relevanceIncreased coronary venous pressure led to a reduction of microvascular resistances in patients with microvascular angina, a mechanism with potential implications for the therapy of this complex disease.Trial registrationClinicalTrials.gov Identifier: NCT05034224.

Project description:BACKGROUND:Stable angina is a common cardiovascular disease with high mortality and a poor prognosis. Although there are various interventions against stable angina, none are able to significantly reduce the mortality rate. Guanxinjing capsule (GXJ) is made from the classical Chinese prescription Xuefuzhuyutang (). Both basic research and clinical studies have shown that GXJ can relieve the symptoms of angina, but currently, the effects of GXJ lack high-quality clinical evidence. The aim of this study was to evaluate the clinical effectiveness and safety of GXJ compared with placebo. METHODS/DESIGN:This multicentre, blinded, randomized trial will be conducted with a total of 120 participants diagnosed with chronic stable angina (Qi deficiency and blood stasis syndrome). Using a central randomization system, participants will be randomized (1:1) into groups receiving either GXJ or placebo for 8 weeks. After a 2-week run-in period, eligible patients will receive either GXJ or placebo (4 pills, three times daily) for 8 weeks in addition to conventional treatment. The primary outcomes include changes in the total exercise time on exercise tolerance tests and changes in the integral scores of angina symptoms. The secondary outcome measures include changes in the maximal estimated workload, changes in time to a 1 mm ST-segment depression or raise, changes in the time to onset of angina during exercise tolerance testing, changes in the total score of traditional Chinese medicine syndrome, and changes in the total score of the Generalized Anxiety Disorder 7-item assessment between baseline and week 8. Other outcome measures will also be assessed. All exercise tolerance tests use a standard Bruce multistage exercise test protocol. Adverse events will be monitored throughout the trial. DISCUSSION:This study will investigate whether GXJ can alleviate clinical symptoms, increase the angina-free walking time, and improve quality of life in patients with chronic stable angina (Qi deficiency and blood stasis syndrome). The results of this study will provide clinical evidence for the application of GXJ to the treatment of stable angina. TRIAL REGISTRATION:Chinese Clinical Trial Registry, ChiCTR1800014258 . Registered on 2 January 2018.

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Comprehensive treatment of microvascular angina in overweight women - a randomized controlled pilot trial.

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Comprehensive treatment of microvascular angina in overweight women - a randomized controlled pilot trial.

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