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Effective evaluation of Vericiguat in reducing pulmonary resistance in heart failure with combined postcapillary pulmonary hypertension

Effective evaluation of Vericiguat in reducing pulmonary resistance in heart failure with combined postcapillary pulmonary hypertension:a randomized controlled, open-label, single-center clinical trial

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2300072617
Enrollment
Unknown
Registered
2023-06-19
Start date
2023-06-30
Completion date
Unknown
Last updated
2023-06-26

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

Conditions

Heart failure wtih combined postcapillary pulmonary hypertension

Interventions

Intervention group:Vericiguat in combination with basic therapeutic drugs (ARNI or ACEI or ARB, beta-blockers, diuretics, digoxin, SGLT-2 inhibitors, etc.)
Control group:Basic therapeutic drugs (ARNI or ACEI or ARB, beta-blockers, diuretics, digoxin, SGLT-2 inhibitors, etc.)

Sponsors

Affiliated Hospital of Guangdong Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: [1]. Unrestricted gender; [2]. Age = 18 years and = 80 years; [3]. Subjects with a diagnosis of heart failure and NYHA cardiac function class II to IV; [4]. The diagnostic criteria for combined postcapillary pulmonary hypertension was met by right heart catheterization (mPAP > 20 mmHg and PAWP > 15 mmHg and PVR > 2 WU); [5]. Signing the informed consent form (ICF) voluntarily and being able to comply with the study's treatment protocol, visits, laboratory tests and other requirements.

Exclusion criteria

Exclusion criteria: [1]. Those with co-morbid thyroid disease requiring treatment; [2]. Combined with congenital heart disease; [3]. Co-existing acute exacerbations of chronic obstructive pulmonary disease; [4]. Pregnant or pregnant in preparation; [5]. Participants with pre-existing symptomatic hypotension or basal blood pressure systolic (SBP) = 90 mmHg; [6]. Subjects with eGFR <15 mL/min/1.73 m2 at initiation of therapy or on dialysis; [7]. Participants who are preparing for or taking a phosphodiesterase type 5 (PDE5) inhibitor (e.g. sildenafil); [8]. Participants who, in the judgment of the investigator, are unable to complete the study or to comply with the requirements of the study.

Design outcomes

Primary

MeasureTime frame
Variation of pulmonary vascular resistance;

Secondary

MeasureTime frame
Variation of 6-minute walking test;Incidence of major adverse events;Cardiovascular mortality;Variation of NT-proBNP;Changes of cardiac color Doppler parameters;Change in mPAP;Change in PAWP;Change in CO;

Countries

China

Contacts

Public ContactMing Li

Affiliated Hospital of Guangdong Medical University

leonlai@gdmu.edu.cn+86 138 2482 8947

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026