NCT05230901 (Reduce-MFA) is a Phase 3 clinical trial of Standard of Care in Aortic Stenosis, Severe, sponsored by University Medical Center Goettingen.

Who is sponsoring NCT05230901?

NCT05230901 is sponsored by University Medical Center Goettingen.

What drugs are being tested in NCT05230901?

Interventions in NCT05230901: Standard of Care, Spironolactone 25mg, Dihydralazine.

What condition does NCT05230901 study?

NCT05230901 studies Aortic Stenosis, Severe.

Is NCT05230901 still recruiting?

NCT05230901 is currently status unknown. Last updated 27 June 2022.

Last reviewed 2022-06-27 · How we verify

NCT05230901: Reduce-MFA

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Effect of Antifibrotic Therapy on Regression of Myocardial Fibrosis After Transcatheter Aortic Valve Implantation (TAVI) in Aortic Stenosis Patients With High Fibrotic Burden

Status unknown Phase 3 Last updated 27 June 2022

What this trial tests

Phase 3 trial testing Standard of Care in Aortic Stenosis, Severe in 300 participants. Status unknown.

Timeline

23 February 2022

Primary endpoint
1 June 2025

1 March 2026

Quick facts

Lead sponsor	University Medical Center Goettingen
Phase	Phase 3
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	300
Start date	23 February 2022
Primary completion	1 June 2025
Estimated completion	1 March 2026
Sites	1 location across Germany

Drugs / interventions tested

Standard of Care
Spironolactone 25mg — full drug profile →
Dihydralazine (DIHYDRALAZINE) — full drug profile →

Conditions studied

Aortic Stenosis, Severe — all drugs for Aortic Stenosis, Severe →

Sponsor

University Medical Center Goettingen

Who can join

60 and older, any sex, with Aortic Stenosis, Severe. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

Extracellular volume (ECV)-derived matrix volume (measured by CMR)
Time frame: 12 months
Differences between treatment groups in reduction of extracellular volume (ECV)- derived matrix volume (measured by CMR) after 12 months

Sponsor's own description

The aim of the study is to evaluate the effect of antifibrotic therapy on regression of myocardial fibrosis after TAVI in patients with baseline high fibrotic burden. Therefore, patients will be treated with Spironolactone in addition to standard of care, Spioronolactone + Dihydralazine in addition to standard of care or according to standard of care alone without any study medication. First, differences between patients in the control arm and patients randomized to anti-fibrotic therapy will be analyzed. The second analysis will determine, whether dihydralazine medication in addition to spironolactone is able to increase a potential antifibrotic effect. Myocardial fibrosis will be assessed by cardiac magnetic resonance imaging (CMR) before TAVI and 1 year after. Quantification of potentially irreversible replacement fibrosis will be carried out by late gadolinium enhancement (LGE), and quantification of the potentially reversible diffuse interstitial fibrosis will be performed by measurement of the extracellular volume fraction (ECV), thereby deriving matrix volume and cell volume.

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

Single-cell dissection of hepatocellular carcinoma immunity: from heterogeneous subtypes to precision therapeutics.
Liang Y, Wu H, Qiu Y, Mo Q, et al · · 2026 · PMID 41756301 · DOI 10.3389/fimmu.2026.1744845
Estimating myocardial fibrosis in aortic stenosis using the serum collagen type I C-terminal telopeptide to matrix metalloproteinase-1 ratio.
Gersch S, Bengel P, Paul NB, Ravassa S, et al · · 2025 · PMID 39830018 · DOI 10.1002/mco2.70069
Insights into calcific aortic valve stenosis: a comprehensive overview of the disease and advancing treatment strategies
Jain H, Goyal A, Khan A, Khan N, et al · · 2024

Verify or expand the search:

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Other recruiting trials for Aortic Stenosis, Severe

Currently open trials in the same condition.

NCT06818110 — The CardioFit Trial: Exercise Training Before Aortic Valve Surgery · NA · active not recruiting
NCT06596460 — A Study to Obtain Imaging Data in 40 Patients Having Transcatheter Aortic Valve Implantation (TAVI) · NA · recruiting
NCT06377449 — Influence of Lung Ultrasonography on the Prognosis and Postoperative Outcomes in Cardiac Surgical Patients · NA · recruiting
NCT06129799 — Exercise CMR in (p)LF-LG AS · recruiting
NCT05751577 — TRanscatheter Aortic-Valve Implantation With or Without On-site Cardiac Surgery: the TRACS Trial · NA · active not recruiting

Other University Medical Center Goettingen trials

Trials by the same sponsor.

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NCT06921863 — This Study Aims to Quantify Decisional Regret as Well as Quality of Life in Patients With Low- to High-risk Cancer and H · not yet recruiting
NCT07476365 — A Multi-omic Approach to the Identification of Novel Biomarkers in Early Charcot-Marie-Tooth 1A Disease (CMT1A) · recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT05230901 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by University Medical Center Goettingen
Last refreshed: 27 June 2022

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05230901.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing