Statin InTensity to Prevent Coronary Artery Vasculopathy After Heart Transplantation

NCT05251129 | Withdrawn DMC

• 1 other identifier: 2021-13700
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

The investigator's propose to conduct an open-label randomized controlled trial to determine if higher intensity statin (HS) can reduce CAV in comparison to lower intensity statin (LS) after HT. All consecutive patients that meet eligibility criteria will be approached for participation. After heart transplantation, participants (n=70) will be randomized in a 1:1 manner to either HS or LS. Study participation will be for 2 years from the time of randomization. Study outcomes will be compared by research staff blinded to statin group assignment.

Conditions

Vasculopathy

Outcome Measures

Primary Outcomes (1)

• Myocardial Flow Reserve

  Myocardial Flow Reserve measured by cardiac positron emission tomography

  2 year

Secondary Outcomes (4)

• Coronary Vascular Resistance

  2 year

• Change in Global Longitudinal Strain

  baseline, 1 year and 2 year

• Blood level of Low Density Lipoprotein

  baseline, 6, 12, 18, 24 months

• Blood level of High Sensitivity C-Reactive Protein

  baseline, 6, 12, 18, 24 months

Study Arms (2)

Higher Intensity Statin

EXPERIMENTAL

Atorvastatin 80 milligram (mg) oral tablet

Drug: Atorvastatin 80 Mg Oral Tablet

Lower Intensity Statin

ACTIVE COMPARATOR

Pravastatin 40 mg oral tablet

Drug: Pravastatin 40 Mg Oral Tablet

Interventions

Atorvastatin 80 Mg Oral Tablet DRUG

Higher intensity statin

Higher Intensity Statin

Pravastatin 40 Mg Oral Tablet DRUG

Lower intensity statin

Lower Intensity Statin

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Waitlisted for Heart Transplantation
• Capacity to provide informed consent

You may not qualify if:

• History of statin allergy or intolerance
• Hepatic dysfunction
• Redo Heart Transplant
• Awaiting combined heart and liver transplantation

Sponsors & Collaborators

• Montefiore Medical Center: lead

MeSH Terms

Conditions

Vascular Diseases

Interventions

Atorvastatin; Tablets; Pravastatin

Condition Hierarchy (Ancestors)

Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Pyrroles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heptanoic Acids; Fatty Acids; Lipids; Dosage Forms; Pharmaceutical Preparations; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds

Study Officials

• Omar Saeed, MD, MS

  Montefiore Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Open-label, randomized controlled trial

Study Record Dates

• First Submitted: December 17, 2021
• First Posted: February 22, 2022
• Study Start: January 1, 2025
• Primary Completion (Estimated): June 1, 2030
• Study Completion (Estimated): June 1, 2030
• Last Updated: January 13, 2025

Record last verified: 2025-01