Decompensated Heart FailurePhase 1NCT07444398
Vericiguat in Decompensated Cardiac Failure: Clinical Insights on Addition to Guidelines Derived Medical Therapy-VERCIG Trial
A Phase 1 study testing Vericiguat tablet and Sacubitril / Valsartan in people with Decompensated Heart Failure, run by Khawaja Danish Ali at 1 site in Pakistan.
Trial summary
This study will compare the outcomes of Vericuguat and placebo in patient with decompensated heart failure . This study will carry out after approval from IERB. Seventy patients fulfilling the inclusion criteria will be enrolled from emergency department. Informed consent will be taken from attendants. Read more about this study
- Who is it for?
- Ages 25 to 65 years
- Conditions the study is for
- Decompensated Heart Failure
- What is being tested?
- Vericiguat tablet and Sacubitril / Valsartan
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 130 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Jan 2026to 31 Mar 2026
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients diagnosed with decompensated heart failure (patients with left ventricular ejection fraction ≤45% presenting with NYHA functional class III-IV symptoms or worsening class II symptoms. Along with elevated natriuretic peptide levels defined as NT-proBNP >1000 pg/mL in patients with sinus rhythm and >1600 pg/mL in patients with atrial fibrillation in the absence of alternative causes of biomarker elevation)
Who cannot join
- Patients with blood pressure <100 mmHg;
- concurrent or anticipated use of long-acting nitrates, soluble guanylate cyclase stimulators, or phosphodiesterase type 5 inhibitors
- use of intravenous inotropes or implantable left ventricular assist devices (on medical record)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Pakistan1 site, 1 recruiting
- Recruiting
Armed Forces Institute of Cardiology. Pakistan
Rawalpindi, Punjab Province, 46000
Prof Dr Muhammad Nadir Khan, MBBS, FCPS, +923219156153, yesnadirkhan@gmail.com
About this study
This study will compare the outcomes of Vericuguat and placebo in patient with decompensated heart failure . This study will carry out after approval from IERB. Seventy patients fulfilling the inclusion criteria will be enrolled from emergency department. Informed consent will be taken from attendants. A detailed history including name, age, gender, duration of heart failure, history of alcoholism, smoking, diabetes, hypertension, EF at baseline and NYHA class will be noted. Patients will be randomly divided in two groups by using lottery method. Outcomes will be assessed at in terms of hospitalization for heart failure, death from cardiovascular event and side effects.
- Conditions
- Decompensated Heart Failure
- Being tested
- Vericiguat tablet, Sacubitril / Valsartan
- Keywords
- Vericuguat, Heart failure, Emergency Department
- Medical subject headings
- Heart Failure, Emergencies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vericiguat tabletDrug
Group A, patients will be prescribed 2.5 mg of vericiguat. Dose will be increased to 5 mg and ultimately to the target dose of 10 mg once daily, as guided by evaluation of blood pressure and clinical symptoms along with standard treatment (sacubitril-valsartan)
Sacubitril / ValsartanDrug
Group A Patients it will be prescribed along with vericiguat but group B patients will have (sacubitril-valsartan) as standard treatment
| Study group | Role | What they receive |
|---|---|---|
| Group A patients who will be prescribed 2.5 mg of vericiguat along with standard treatment | Experimental | Sixty Five patients fulfilling the inclusion criteria will be enrolled from emergency department. Informed consent will be taken from attendants. A detailed history will be noted. patients will be prescribed 2.5 mg of vericiguat. Dose will be increased to 5 mg and ultimately to the target dose of 10 mg once daily, as guided by evaluation of blood pressure and clinical symptoms along with standard treatment (sacubitril-valsartan).All patients will be followed-up in OPD for 3 months. During follow-up, patients will be examined for admission to the hospital for deterioration of heart condition or mortality due to cardiac event and side effects (as per operational definition). All the data will be recorded in Performa. Receives: Drug: Vericiguat tablet; Drug: Sacubitril / Valsartan |
| Group B patients who will be prescribed standard treatment only (sacubitril-valsartan) | Active comparator | Sixty Five patients fulfilling the inclusion criteria will be enrolled from emergency department randomly. Informed consent will be taken from attendants. A detailed history will be noted. Patients will be prescribed standard treatment only (sacubitril-valsartan). All patients will be followed-up in OPD for 3 months. During follow-up, patients will be examined for admission to the hospital for deterioration of heart condition or mortality due to cardiac event and side effects (as per operational definition). All the data will be recorded in Performa. Receives: Drug: Sacubitril / Valsartan |
What is being measured
The primary outcome is the main question the study is designed to answer.
Requirement of hospitalization for heart failure
If Ejection Fraction further reduced and patient need to admit in the hospital for symptoms including pedal edema, pleural effusion, and need intravenous diuretic therapy
Measured: 03 months
Death from cardiovascular event
If patient will die during 3 months follow-up
Measured: 03 months
Secondary outcomes (1)
Side effects
If patient will complaint of mild to moderate gastrointestinal disturbances, Hypotension (BP≥100/60 mmHg) or any other adverse event during 3 months follow-up
Measured: 03 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Mar 2026
- Study start1 Jan 2026
- Primary completion31 Mar 2026 (estimated)
- Study completion31 Mar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Decompensated Heart FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 130 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Khawaja Danish Ali
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Khawaja Danish Ali, Armed Forces Institute of Cardiology, Pakistan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07444398
- Sponsor's protocol ID
- 25
- Status last verified
- Feb 2026
- First submitted
- 26 Feb 2026
- Last updated
- 2 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Vericiguat in Decompensated Cardiac Failure: Clinical Insights on Addition to Guidelines Derived Medical Therapy-VERCIG Trial
- ClinicalTrials.gov ID
- NCT07444398
- Acronym / sponsor ID
- 25
- Conditions
- Decompensated Heart Failure
- Keywords
- Vericuguat, Heart failure, Emergency Department
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 130 participants (estimated)
- Lead sponsor
- Khawaja Danish AliUniversity, hospital or other
- Study start
- 1 Jan 2026 (actual)
- Primary completion
- 31 Mar 2026 (estimated)
- Study completion
- 31 Mar 2026 (estimated)
- First posted
- 2 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will compare the outcomes of Vericuguat and placebo in patient with decompensated heart failure . This study will carry out after approval from IERB. Seventy patients fulfilling the inclusion criteria will be enrolled from emergency department. Informed consent will be taken from attendants. A detailed history including name, age, gender, duration of heart failure, history of alcoholism, smoking, diabetes, hypertension, EF at baseline and NYHA class will be noted. Patients will be randomly divided in two groups by using lottery method. Outcomes will be assessed at in terms of hospitalization for heart failure, death from cardiovascular event and side effects.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A patients who will be prescribed 2.5 mg of vericiguat along with standard treatment | Experimental | Drug: Vericiguat tablet, Drug: Sacubitril / ValsartanSixty Five patients fulfilling the inclusion criteria will be enrolled from emergency department. Informed consent will be taken from attendants. A detailed history will be noted. patients will be prescribed 2.5 mg of vericiguat. Dose will be increased to 5 mg and ultimately to the target dose of 10 mg once daily, as guided by evaluation of blood pressure and clinical symptoms along with standard treatment (sacubitril-valsartan).All patients will be followed-up in OPD for 3 months. During follow-up, patients will be examined for admission to the hospital for deterioration of heart condition or mortality due to cardiac event and side effects (as per operational definition). All the data will be recorded in Performa. |
| Group B patients who will be prescribed standard treatment only (sacubitril-valsartan) | Active comparator | Drug: Sacubitril / ValsartanSixty Five patients fulfilling the inclusion criteria will be enrolled from emergency department randomly. Informed consent will be taken from attendants. A detailed history will be noted. Patients will be prescribed standard treatment only (sacubitril-valsartan). All patients will be followed-up in OPD for 3 months. During follow-up, patients will be examined for admission to the hospital for deterioration of heart condition or mortality due to cardiac event and side effects (as per operational definition). All the data will be recorded in Performa. |
Who may qualify
- Ages
- 25 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients diagnosed with decompensated heart failure (patients with left ventricular ejection fraction ≤45% presenting with NYHA functional class III-IV symptoms or worsening class II symptoms. Along with elevated natriuretic peptide levels defined as NT-proBNP >1000 pg/mL in patients with sinus rhythm and >1600 pg/mL in patients with atrial fibrillation in the absence of alternative causes of biomarker elevation)
Key exclusion criteria (3 listed)
- Patients with blood pressure <100 mmHg;
- concurrent or anticipated use of long-acting nitrates, soluble guanylate cyclase stimulators, or phosphodiesterase type 5 inhibitors
- use of intravenous inotropes or implantable left ventricular assist devices (on medical record)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Vericiguat tabletGroup A, patients will be prescribed 2.5 mg of vericiguat. Dose will be increased to 5 mg and ultimately to the target dose of 10 mg once daily, as guided by evaluation of blood pressure and clinical symptoms along with standard treatment (sacubitril-valsartan) | Drug | Group A patients who will be prescribed 2.5 mg of vericiguat along with standard treatment |
| Sacubitril / ValsartanGroup A Patients it will be prescribed along with vericiguat but group B patients will have (sacubitril-valsartan) as standard treatment | Drug | Group A patients who will be prescribed 2.5 mg of vericiguat along with standard treatment, Group B patients who will be prescribed standard treatment only (sacubitril-valsartan) |
Primary outcome
Requirement of hospitalization for heart failure
Time frame: 03 months
If Ejection Fraction further reduced and patient need to admit in the hospital for symptoms including pedal edema, pleural effusion, and need intravenous diuretic therapy
Death from cardiovascular event
Time frame: 03 months
If patient will die during 3 months follow-up
1 secondary outcome
Side effects
Time frame: 03 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Mar 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Vericiguat tablet and Sacubitril / Valsartan in people with Decompensated Heart Failure, run by Khawaja Danish Ali at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 2 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Dr Khawaja Danish Ali, MBBS (+923448890893, khawajadanishali@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Requirement of hospitalization for heart failure (time frame: 03 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Mar 2026.