Heart FailureNCT02068937
Effectiveness of a Diuretic Algorithm in Clinical Stability in Heart Failure Patients
A study testing Furosemide and Phone contact and Furosemide in people with Heart Failure, run by Hospital de Clinicas de Porto Alegre at 1 site in Brazil.
Trial summary
One of the challenges in treating patients with heart failure (HF) is achieving clinical stability and reducing the hospital readmission rate. A diuretic dose adjustment algorithm developed in the United States (Diuretic Treatment Algorithm, DTA) and later validated for use in Brazil (as the Algoritmo de Ajuste de… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure
- What is being tested?
- Furosemide and Phone contact and Furosemide
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 206 participants
- Where
- 1 siteBrazil
- Study dates
- May 2013to Dec 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients of both genders
- Age ≥ 18 years
- Diagnosed with systolic HF
- Able to monitor body weight at home
- Using furosemide
Who cannot join
- Those who are not able to make return visits or participate in telephone contact, and those on renal replacement therapy.
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Hospital de Clínicas de Porto Alegre
Porto Alegre, Rio Grande do Sul, 90035 903
About this study
Official title: Effectiveness of a Diuretic Algorithm in Clinical Stability and Readmissions in Heart Failure Patients
One of the challenges in treating patients with heart failure (HF) is achieving clinical stability and reducing the hospital readmission rate. A diuretic dose adjustment algorithm developed in the United States (Diuretic Treatment Algorithm, DTA) and later validated for use in Brazil (as the Algoritmo de Ajuste de Diurético, AAD) has proved feasible and readily applicable, but its effect on clinical outcomes has yet to be assessed. This report aims to describe a randomized clinical trial protocol designed to assess the effectiveness of the AAD and of nonpharmacologic management in improving clinical stability and reducing the readmission rate at 90 days in patients with HF.
Read the detailed description
A PROBE (prospective randomized open blinded endpoint) parallel-group design will be used. Adult patients with a diagnosis of reduced ejection fraction HF, who are being treated at a specialized HF clinic are being recruited. Those with indications for loop diuretic dose adjustment during routine clinic visits will be randomized to take part in the trial. Participants in the intervention group (IG) shall have their diuretic doses adjusted in accordance with the AAD and receive four telephone calls (one per week) over 30 days to reinforce guidance on nonpharmacological management (fluid and sodium restriction). Participants in the control group (CG) shall have their diuretic doses adjusted by a physician during the first trial visit and shall not receive any telephone calls. Patients in both groups shall return at 1 month for face-to-face reassessment. The study endpoints shall comprise readmission and/or emergency department visits due to HF decompensation within 90 days and clinical instability. All participants shall be required to have a scale at home (or easy access to one), a telephone number, agree to telephone-based follow-up, and be available to return for a 1-month trial visit. Overall, 135 patients are expected to be enrolled in each group.
- Conditions
- Heart Failure
- Being tested
- Furosemide and Phone contact, Furosemide
- Keywords
- Heart Failure, Therapy, Diuretics, Algorithms
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Furosemide and Phone contactDrug
Also called phone calls
The intervention group is conducted by a nurse in a systematic way during one time per week. If signs and symptoms of congestion, the dose of diuretic ( furosemide ) is revised , nonpharmacological guidelines are provided. According to the algorithm 1KG weight changes are indicative of modifying the diuretic dose , with the addition or reduction 1 tablet a day (1 tablet equivalent to 40 milligrams of furosemide)
FurosemideDrug
Also called Control Group
This group received just diuretic adjusted (Furosemide 40 milligrams) by the doctor on the baseline.
| Study group | Role | What they receive |
|---|---|---|
| Control Group | Active comparator | In the control group, patients just diuretic adjusted (Furosemide 40 milligrams) by the doctor on the baseline. The patients do not receive phone calls neither advising on non-pharmacological treatment; The medication is adjusted by the doctor during the initial evaluation of study baseline. Receives: Drug: Furosemide |
| Furosemide and Phone contact | Experimental | The intervention group is conducted by a nurse in a systematic way during one time per week. If signs and symptoms of congestion, the dose of diuretic ( furosemide ) is revised , nonpharmacological guidelines are provided. According to the algorithm 1KG weight changes are indicative of modifying the diuretic dose , with the addition or reduction 1 tablet a day. Receives: Drug: Furosemide and Phone contact |
What is being measured
The primary outcome is the main question the study is designed to answer.
Compose outcome with readmission and/or emergency department visits due to HF decompensation within 90 days and clinical instability.
Measured: 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2014 (estimated)
- Study startMay 2013
- Primary completionDec 2017
- Study completionDec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- More trials run by Hospital de Clinicas de Porto AlegreThe sponsor's other registered studies.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 206 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital de Clinicas de Porto Alegre
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Eneida R Rabelo da Silva, ScD, Principal investigator, HCPA and UFRGS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02068937
- Sponsor's protocol ID
- GPPG/HCPA 10-0376
- Status last verified
- Apr 2020
- First submitted
- 17 Feb 2014
- Last updated
- 22 Apr 2020
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Publications
Feijo MK, Ruschel KB, Bernardes D, Ferro EB, Rohde LE, Biolo A, Rabelo da Silva ER. Effects of a diuretic adjustment algorithm protocol on heart failure admissions: A randomized clinical trial. J Telemed Telecare. 2021 Jun;27(5):288-297. doi: 10.1177/1357633X211009640. Epub 2021 May 9.
PubMed 33966521Feijo MK, Biolo A, Ruschel KB, Orlandin L, Aliti GB, Rabelo-Silva ER. Effect of a diuretic adjustment algorithm and nonpharmacologic management in patients with heart failure: study protocol for a randomized controlled trial. Trials. 2015 Feb 8;16:44. doi: 10.1186/s13063-015-0559-7.
PubMed 25885424
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of a Diuretic Algorithm in Clinical Stability and Readmissions in Heart Failure Patients
- ClinicalTrials.gov ID
- NCT02068937
- Acronym / sponsor ID
- GPPG/HCPA 10-0376
- Conditions
- Heart Failure
- Keywords
- Heart Failure, Therapy, Diuretics, Algorithms
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 206 participants (actual)
- Lead sponsor
- Hospital de Clinicas de Porto AlegreUniversity, hospital or other
- Study start
- May 2013 (actual)
- Primary completion
- Dec 2017 (actual)
- Study completion
- Dec 2017 (actual)
- First posted
- 21 Feb 2014 (estimated)
- 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.
One of the challenges in treating patients with heart failure (HF) is achieving clinical stability and reducing the hospital readmission rate. A diuretic dose adjustment algorithm developed in the United States (Diuretic Treatment Algorithm, DTA) and later validated for use in Brazil (as the Algoritmo de Ajuste de Diurético, AAD) has proved feasible and readily applicable, but its effect on clinical outcomes has yet to be assessed. This report aims to describe a randomized clinical trial protocol designed to assess the effectiveness of the AAD and of nonpharmacologic management in improving clinical stability and reducing the readmission rate at 90 days in patients with HF.
Detailed description
A PROBE (prospective randomized open blinded endpoint) parallel-group design will be used. Adult patients with a diagnosis of reduced ejection fraction HF, who are being treated at a specialized HF clinic are being recruited. Those with indications for loop diuretic dose adjustment during routine clinic visits will be randomized to take part in the trial. Participants in the intervention group (IG) shall have their diuretic doses adjusted in accordance with the AAD and receive four telephone calls (one per week) over 30 days to reinforce guidance on nonpharmacological management (fluid and sodium restriction). Participants in the control group (CG) shall have their diuretic doses adjusted by a physician during the first trial visit and shall not receive any telephone calls. Patients in both groups shall return at 1 month for face-to-face reassessment. The study endpoints shall comprise readmission and/or emergency department visits due to HF decompensation within 90 days and clinical instability. All participants shall be required to have a scale at home (or easy access to one), a telephone number, agree to telephone-based follow-up, and be available to return for a 1-month trial visit. Overall, 135 patients are expected to be enrolled in each group.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control Group | Active comparator | Drug: FurosemideIn the control group, patients just diuretic adjusted (Furosemide 40 milligrams) by the doctor on the baseline. The patients do not receive phone calls neither advising on non-pharmacological treatment; The medication is adjusted by the doctor during the initial evaluation of study baseline. |
| Furosemide and Phone contact | Experimental | Drug: Furosemide and Phone contactThe intervention group is conducted by a nurse in a systematic way during one time per week. If signs and symptoms of congestion, the dose of diuretic ( furosemide ) is revised , nonpharmacological guidelines are provided. According to the algorithm 1KG weight changes are indicative of modifying the diuretic dose , with the addition or reduction 1 tablet a day. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients of both genders
- Age ≥ 18 years
- Diagnosed with systolic HF
- Able to monitor body weight at home
- Using furosemide
Key exclusion criteria (1 listed)
- Those who are not able to make return visits or participate in telephone contact, and those on renal replacement therapy.
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 |
|---|---|---|
| Furosemide and Phone contactAlso: phone callsThe intervention group is conducted by a nurse in a systematic way during one time per week. If signs and symptoms of congestion, the dose of diuretic ( furosemide ) is revised , nonpharmacological guidelines are provided. According to the algorithm 1KG weight changes are indicative of modifying the diuretic dose , with the addition or reduction 1 tablet a day (1 tablet equivalent to 40 milligrams of furosemide) | Drug | Furosemide and Phone contact |
| FurosemideAlso: Control GroupThis group received just diuretic adjusted (Furosemide 40 milligrams) by the doctor on the baseline. | Drug | Control Group |
Primary outcome
Compose outcome with readmission and/or emergency department visits due to HF decompensation within 90 days and clinical instability.
Time frame: 90 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Apr 2020.
- Derived from this study: PubMed 33966521Feijo MK, Ruschel KB, Bernardes D, Ferro EB, Rohde LE, Biolo A, Rabelo da Silva ER. Effects of a diuretic adjustment algorithm protocol on heart failure admissions: A randomized clinical trial. J Telemed Telecare. 2021 Jun;27(5):288-297. doi: 10.1177/1357633X211009640. Epub 2021 May 9.
- Derived from this study: PubMed 25885424Feijo MK, Biolo A, Ruschel KB, Orlandin L, Aliti GB, Rabelo-Silva ER. Effect of a diuretic adjustment algorithm and nonpharmacologic management in patients with heart failure: study protocol for a randomized controlled trial. Trials. 2015 Feb 8;16:44. doi: 10.1186/s13063-015-0559-7.
- Individual participant dataSharing planned: Undecided
Related trials for Heart Failure
RecruitingPhase 3
Trial Investigating the Efficacy and Safety of Weekly Lonapegsomatropin Compared to Daily Somatropin in Children and Adolescents With Short Stature or Growth Failure Due to Growth Hormone Sufficient Disorders
Turner Syndrome, Short Stature Homeobox Gene Mutation
RecruitingObservational study
Heart Failure and Aortic Stenosis Transcriptome
Heart Failure, Aortic Stenosis
Active, not recruiting
REsynchronization Comparison In LBBB and Normal or Mildly Reduced VENTricular Function With CRT (REINVENT-CRT)
Left Ventricular Ejection Fraction, Heart Failure (HF)
RecruitingObservational study
Product Performance Report: Evaluate Long-term Reliability & Performance of Medtronic Marketed Cardiac Therapy Products
Arrhythmia, Bradycardia
Recruiting
Determining Efficacy of an Artificial Intelligence-based System for Heart Failure Detection Through Interpretation of Electrocardiograms (DECISION)
Heart Failure, Cardiovascular Risk Factors
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. This study is not recruiting at the moment.
Eneida R Rabelo da Silva, ScD principal investigator
HCPA and UFRGS
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Furosemide and Phone contact and Furosemide in people with Heart Failure, run by Hospital de Clinicas de Porto Alegre at 1 site in Brazil.
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 5 inclusion and 1 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: finished, as of the sponsor's last update on 22 Apr 2020. 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 Brazil. 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Compose outcome with readmission and/or emergency department visits due to HF decompensation within 90 days and clinical instability. (time frame: 90 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02068937, which also lists 2 linked publications.
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 22 Apr 2020.