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Evaluation of a randomized comparison between patients with coronary artery disease associated with ischemic cardiomyopathy submitted to medical or surgical treatment: MASS-VI (HF)

Hypotheses, rationale, design and methods for prognostic evaluation of a randomized comparison between patients with coronary artery disease associated with ischemic cardiomyopathy submitted to medical or surgical treatment. MASS-VI (HF).

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN77449548
Enrollment
600
Registered
2019-10-10
Start date
2019-09-19
Completion date
Unknown
Last updated
2025-11-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Coronary artery disease Circulatory System Coronary artery disease

Interventions

Participants will be randomised to receive either revascularization or medical therapy. In all cases, patients will be treated by optimal medical therapy that will include maximum-tolerated beta-block

Sponsors

Fundação Zerbini
Lead Sponsor
Fundação de Amparo à Pesquisa do Estado de São Paulo
Collaborator

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Coronary artery disease (CAD) associated with documented ischemic cardiomyopathy subject to surgical revascularization

Exclusion criteria

Exclusion criteria: 1. Unsuitable coronary anatomy for revascularization 2. Prior surgical revascularization 3. Implantable heart devices 4. Terminal chronic kidney disease 5. Refusal to sign consent form

Design outcomes

Primary

MeasureTime frame
Combined primary endpoints will be considered as those that occurred during the study: death from any cause, nonfatal myocardial infarction, stroke and unstable angina requiring additional intervention. All patients will be followed at outpatient visits every 6 months for 5 years

Secondary

MeasureTime frame
Secondary endpoints, during the study follow-up, will be the graduation of anginal symptoms and also of heart failure. Cardiac decompensation hospitalization will be considered a secondary event. All patients will be followed at outpatient visits every 6 months for 5 year.

Countries

Brazil

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 18, 2026