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New treatment option for Heart Failure
Official title Management of Patients With Heart Failure at Home After Hospital Discharge
ClinicalTrials.gov ID: NCT06576752
What this study is testing
- What it's testing
- This study aims to assess whether patients with acute heart failure (HF) can achieve the same level of HF-therapies by digital follow-up at home as compared to hospital visits according to the STRONG-HF strategy. Patients admitted to hospital with acute HF will be enrolled and randomized to either follow-up at the hospital out-patient clinic or digital follow-up at home.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Hospital admission within the 72 hours prior to screening for acute HF.
- NT-proBNP ≥ 1,000 pg/mL measured during the hospitalization
- Systolic blood pressure ≥ 100 mmHg and of heart rate ≥ 60 bpm within 24 hours before randomization
- Serum potassium ≤ 5.0 mEq/L (mmol/L).
- ≤ ½ the optimal dose of ACEi/ARB/ARNi or beta-blocker or MRA.
You likely can't join if
- Age below 18 or above 85 years.
- Clearly documented intolerance to high doses of beta-blockers
- Clearly documented intolerance to high doses of renin-angiotensin system (RAS) blockers (both ACEi and ARB).
- Renal disease or estimated glomerular filtration rate (eGFR) below 30 mL/min/1.73m2 at screening or history of dialysis.
- Prior (defined as less than 30 days from screening) or current enrollment in a HF intervention or participation in an investigational drug or device...
- Index event (admission for acute HF) triggered primarily by a completely reversable etiology so that it is unlikely the patient will be classified...
See the full eligibility criteria
- Hospital admission within the 72 hours prior to screening for acute HF.
- NT-proBNP ≥ 1,000 pg/mL measured during the hospitalization
- Systolic blood pressure ≥ 100 mmHg and of heart rate ≥ 60 bpm within 24 hours before randomization
- Serum potassium ≤ 5.0 mEq/L (mmol/L).
- ≤ ½ the optimal dose of ACEi/ARB/ARNi or beta-blocker or MRA.
- Written informed consent to participate in the study.
- Age below 18 or above 85 years.
- Clearly documented intolerance to high doses of beta-blockers
- Clearly documented intolerance to high doses of renin-angiotensin system (RAS) blockers (both ACEi and ARB).
- Renal disease or estimated glomerular filtration rate (eGFR) below 30 mL/min/1.73m2 at screening or history of dialysis.
- Prior (defined as less than 30 days from screening) or current enrollment in a HF intervention or participation in an investigational drug or device study within the 30 days prior to screening
- Index event (admission for acute HF) triggered primarily by a completely reversable etiology so that it is unlikely the patient will be classified with chronic HF after discharge, such as Takotsubo syndrome (stress...
- Severe non-adherence to medications
- Psychiatric or neurological disorder, cirrhosis, or active malignancy leading to a life expectancy less than 6 months.
- History of heart transplant or on a transplant list, or using or planned to be implanted with a ventricular assist device.
- Uncorrected thyroid disease, active myocarditis, or known amyloid or hypertrophic obstructive cardiomyopathy.
- Inability to comply with all study requirements, due to major co-morbidities, social or financial issues, or a history of noncompliance with medical regimens, that might compromise the patients ability to understand...
- Low digital competency classified as inability to handle a smartphone or tablet.
- Language barriers requiring the need for an external interpreter.
- Pregnant or nursing (lactating) women.
The study team makes the final eligibility decision.
Where it's taking place
- Lørenskog, Akershus, Norway
- Drammen, Vestre Viken, Norway
- Arendal, Norway
- Ålesund, Norway
- Hamar, Norway
- Levanger, Norway
- Moss, Norway
- Oslo, Norway
- Stavanger, Norway
- Tromsø, Norway
- Tønsberg, Norway
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Lørenskog, Akershus, Norway; Drammen, Vestre Viken, Norway; Arendal, Norway; Ålesund, Norway; Hamar, Norway; Levanger, Norway and 5 more location(s). Enter your location above to see the nearest site and check your eligibility.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.