Chronic Heart FailureROXICNCT05913739
Oxygen Therapy in Patients With Chronic Heart Failure With Reduced Ejection Fraction
A study testing Oxygen Therapy in people with Chronic Heart Failure and Oxygen Deficiency, run by Institut d'Investigació Biomèdica de Girona Dr. Josep Trueta at 1 site in Spain.
Trial summary
The purpose of this study is to assess patients with chronic heart failure and moderate-severe ventricular dysfunction (left ventricular ejection fraction (FEVE) <40%) with nocturnal desaturation (mean Oxygen saturation (SatO2) <90% and/or Cummulative time (TC) <90% > 22 minutes) without underlying respiratory… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Heart Failure, Oxygen Deficiency
- What is being tested?
- Oxygen Therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1 participants
- Where
- 1 siteSpain
- Study dates
- 1 Jul 2022to 31 Jul 2024
- 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 > 18 years old.
- Diagnosis and clinic of chronic heart failure with ventricular dysfunction with left ventricular ejection fraction (LVEF) <40% under optimal medical treatment regardless of its etiology and having presented at least one episode of decompensation (visits to the emergency room, hospitalizations and/or need for intravenous depletive treatment) during the last year.
- Nocturnal desaturation defined as mean SatO2 <90% and/or Cummulative time (TC) <90>22 minutes to nocturnal pulse oximetry done at home.
- Signed informed consent
Who cannot join
- Chronic lung disease (includes chronic obstructive pulmonary disease with Pulmonary respiratory function (PRF) (forced expiratory volume at one second/forced vital capacity (FEV1/FVC) <70%), diffuse interstitial diseases, pulmonary hypertension of respiratory).
- Obstructive sleep apnea-hypopnea syndrome (OSAHS) with Apnea hypopnea index (AHI) > 14.9.
- Previous treatment with oxygen therapy.
- Not agreeing to attend periodic cardiology visits.
- Being part of other clinical studies that contraindicate an intervention.
- Pregnant or breastfeeding women.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Impact of Oxygen Therapy on Readmissions of Patients With Chronic Heart Failure With Reduced Ejection Fraction
The purpose of this study is to assess patients with chronic heart failure and moderate-severe ventricular dysfunction (left ventricular ejection fraction (FEVE) <40%) with nocturnal desaturation (mean Oxygen saturation (SatO2) <90% and/or Cummulative time (TC) <90% > 22 minutes) without underlying respiratory disease, oxygen treatment during hours of night rest will reduce exacerbations, improve the ability to effort, sleep quality and poor prognostic parameters of heart failure, compared to patients not receiving oxygen treatment.
Read the detailed description
36 patients will attend at baseline, monthly, 3-month and 6-monthly visits.
BASELINE VISIT After being informed about the study and potential risks, all patients giving written informed consent, will be randomized (according to the list) receiving oxygen therapy (treatment group) and those not receiving this treatment (control group).
The following information will be collected:
- Demographics, pathological history, concomitant medication.
- Physical examination, vital signs (pressure, heart rate, weight)
- Doppler echocardiography (an echocardiography performed in the last 6 months will be accepted)
- Analytical determination of biomarkers NT-proBNP and ultrasensitive troponin.
- Assessment of baseline functional class by NYHA classification.
- Respiratory function tests: spirometry and diffusion (will accept tests performed in the last 6 months).
- Arterial blood gases.
- Nocturnal respiratory polygraphy.
- Exercise capacity with the 6-minute walk test (P6MM)
- Evaluation of health-related quality of life with the Minnesota questionnaire
- Assessment of sleep quality using the Pittsburgh questionnaire
If the patient belongs to the treatment group, the intervention will begin with oxygen therapy with a static concentrator and nasal cannula during the night at home, with a minimum compliance of six hours, following the usual clinical practice. Overnight pulse oximetry at home with oxygen will be performed to confirm if the prescribed flow rate is adequate to achieve a mean SatO2 >90% and/or that the correction of the CT90. If this is not achieved, it will be repeated, modifying the oxygen flow until the target is reached.
The control group will not undergo this intervention.
The rest of the medical treatment will be carried out according to the usual protocol of the Heart Failure Unit.
Follow up visits:
Clinical follow-up will be done at one month, three months and six months after the start of the intervention in the Chronic Respiratory Pathology Unit of Pneumology.
At 1 and 3 months
- Analytical determination of biomarkers nt-proBNP and ultrasensitive troponin (TnThs).
- Baseline functional class will be collected by New York Heart Association (NYHA) classification.
- Physical examination, vital signs (blood pressure (BP), Heart rate (HR), weight).
- Adverse effects and concomitant medication.
At 6 months
- Analytical determination of biomarkers nt-proBNP and ultrasensitive troponin (TnThs).
- Baseline functional class by NYHA classification will be collected.
- Physical examination, vital signs (BP, HR, weight).
- Evaluation of exercise capacity will be done by means of the 6-minute walk test (PM6M).
- Nocturnal pulse oximetry of control: treatment group with oxygen to evaluate the response and control group without oxygen to evaluate the evolution.
- Assessment of health-related quality of life with the Minnesota questionnaire.
- Sleep quality will be assessed using the Pittsburgh questionnaire.
- Adverse effects and concomitant medication.
In the follow-up periods (1, 3 and 6 months), the number of decompensations will be recorded:
- Hospitalizations for heart failure.
- Emergency care for heart failure requiring at least one dose of intravenous diuretic treatment.
- Need for outpatient intravenous depletive treatment due to the presence of congestive signs.
The study will be considered completed after 6 months of follow-up.
- Conditions
- Chronic Heart Failure, Oxygen Deficiency
- Being tested
- Oxygen Therapy
- Keywords
- oxygen therapy
- Medical subject headings
- Hypoxia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oxygen TherapyOther
Nocturnal oxygen therapy minimum 6 hours
| Study group | Role | What they receive |
|---|---|---|
| Oxygen Therapy | Active comparator | Participants received nocturnal oxygen therapy (minimum 6 hours) for 6 months. Receives: Other: Oxygen Therapy |
| No Oxygen Therapy | No intervention | Participants will not received oxygen therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Nocturnal oxygen therapy at home in patients with heart failure heart rate and nocturnal desaturation can reduce the number of heart failure decompensations cardiac arrest.
To assess whether treatment with nocturnal oxygen therapy at home in patients with heart failure heart rate and nocturnal desaturation (mean SatO2 <90% and/or CT <90%>22 minutes) no AOS manages to reduce the number of heart failure decompensations cardiac arrest (hospitalizations, visits to the emergency room or the need for depletive treatment intravenously) compared with patients not receiving oxygen therapy.
Measured: changes from baseline to 6th month
Secondary outcomes (4)
Oxygen during the night rest is accompanied by reduction of the biomarker NTproBNP (pg/mL). Oxygen during the night rest is accompanied by reduction the biomarker TnThs (pg/mL).
To analyze if the treatment with oxygen during the night rest is accompanied by reduction the biomarkers NTproBNP(pg/mL) and TnThs (pg/mL).
Measured: changes from baseline to 6th month
Nocturnal oxygen therapy on symptoms using the class function of the NYHA, in the capacity of effort (P6MM).
To assess the benefit of nocturnal oxygen therapy on symptoms using the class function of the NYHA, in the capacity of effort (P6MM).
Measured: changes from baseline to 6th month
Nocturnal oxygen therapy on symptoms using the class function of the NYHA, in the quality of life (Minnesota score)
To assess the benefit of nocturnal oxygen therapy on symptoms using the class function of the NYHA, in the quality of life (Minnesota score)
Measured: changes from baseline to 6th month
Nocturnal oxygen therapy on symptoms using the class function of the NYHA, in the quality of the dream (pittsburg score).
To assess the benefit of nocturnal oxygen therapy on symptoms using the class function of the NYHA, in the quality of the dream (pittsburg score).
Measured: changes from baseline to 6th month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2023
- Study start1 Jul 2022
- Primary completion31 Jul 2024
- Study completion31 Jul 2024
Why it stopped: Difficulty in recruitment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (18)Papers the sponsor has linked to this study.
- Other trials for Chronic 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A randomization of the patients will be carried out receiving oxygen therapy (treatment group) and those not receiving this treatment (control group): randomization will be done according to list
- Masking
- None (open label)
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institut d'Investigació Biomèdica de Girona Dr. Josep Trueta
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marc Bonnin, Institut d'Investigació Biomèdica de Girona Dr. Josep Trueta
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05913739
- Sponsor's protocol ID
- ROXIC
- Acronym
- ROXIC
- Status last verified
- Oct 2024
- First submitted
- 8 Feb 2023
- Last updated
- 8 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All individual participant data (IPD) collected data can be shared as long as it is for research collaboration
Publications
Bekfani T, Abraham WT. Current and future developments in the field of central sleep apnoea. Europace. 2016 Aug;18(8):1123-34. doi: 10.1093/europace/euv435. Epub 2016 May 26.
PubMed 27234869Oldenburg O, Wellmann B, Buchholz A, Bitter T, Fox H, Thiem U, Horstkotte D, Wegscheider K. Nocturnal hypoxaemia is associated with increased mortality in stable heart failure patients. Eur Heart J. 2016 Jun 1;37(21):1695-703. doi: 10.1093/eurheartj/ehv624. Epub 2015 Nov 26.
PubMed 26612581Khayat R, Jarjoura D, Porter K, Sow A, Wannemacher J, Dohar R, Pleister A, Abraham WT. Sleep disordered breathing and post-discharge mortality in patients with acute heart failure. Eur Heart J. 2015 Jun 14;36(23):1463-9. doi: 10.1093/eurheartj/ehu522. Epub 2015 Jan 29.
PubMed 25636743Watanabe E, Kiyono K, Matsui S, Somers VK, Sano K, Hayano J, Ichikawa T, Kawai M, Harada M, Ozaki Y. Prognostic Importance of Novel Oxygen Desaturation Metrics in Patients With Heart Failure and Central Sleep Apnea. J Card Fail. 2017 Feb;23(2):131-137. doi: 10.1016/j.cardfail.2016.09.004. Epub 2016 Sep 9.
PubMed 27615064Gottlieb JD, Schwartz AR, Marshall J, Ouyang P, Kern L, Shetty V, Trois M, Punjabi NM, Brown C, Najjar SS, Gottlieb SS. Hypoxia, not the frequency of sleep apnea, induces acute hemodynamic stress in patients with chronic heart failure. J Am Coll Cardiol. 2009 Oct 27;54(18):1706-12. doi: 10.1016/j.jacc.2009.08.016.
PubMed 19850211Bradley TD, Logan AG, Kimoff RJ, Series F, Morrison D, Ferguson K, Belenkie I, Pfeifer M, Fleetham J, Hanly P, Smilovitch M, Tomlinson G, Floras JS; CANPAP Investigators. Continuous positive airway pressure for central sleep apnea and heart failure. N Engl J Med. 2005 Nov 10;353(19):2025-33. doi: 10.1056/NEJMoa051001.
PubMed 16282177Cowie MR, Woehrle H, Wegscheider K, Angermann C, d'Ortho MP, Erdmann E, Levy P, Simonds AK, Somers VK, Zannad F, Teschler H. Adaptive Servo-Ventilation for Central Sleep Apnea in Systolic Heart Failure. N Engl J Med. 2015 Sep 17;373(12):1095-105. doi: 10.1056/NEJMoa1506459. Epub 2015 Sep 1.
PubMed 26323938Damy T, Margarit L, Noroc A, Bodez D, Guendouz S, Boyer L, Drouot X, Lamine A, Paulino A, Rappeneau S, Stoica MH, Dubois-Rande JL, Adnot S, Hittinger L, d'Ortho MP. Prognostic impact of sleep-disordered breathing and its treatment with nocturnal ventilation for chronic heart failure. Eur J Heart Fail. 2012 Sep;14(9):1009-19. doi: 10.1093/eurjhf/hfs085. Epub 2012 Jun 22.
PubMed 22730336Yumino D, Bradley TD. Central sleep apnea and Cheyne-Stokes respiration. Proc Am Thorac Soc. 2008 Feb 15;5(2):226-36. doi: 10.1513/pats.200708-129MG.
PubMed 18250216Levi-Valensi P, Weitzenblum E, Rida Z, Aubry P, Braghiroli A, Donner C, Aprill M, Zielinski J, Wurtemberger G. Sleep-related oxygen desaturation and daytime pulmonary haemodynamics in COPD patients. Eur Respir J. 1992 Mar;5(3):301-7.
PubMed 1572442Toyama T, Seki R, Kasama S, Isobe N, Sakurai S, Adachi H, Hoshizaki H, Oshima S, Taniguchi K. Effectiveness of nocturnal home oxygen therapy to improve exercise capacity, cardiac function and cardiac sympathetic nerve activity in patients with chronic heart failure and central sleep apnea. Circ J. 2009 Feb;73(2):299-304. doi: 10.1253/circj.cj-07-0297. Epub 2008 Dec 27.
PubMed 19122308Ponikowski P, Voors AA, Anker SD, Bueno H, Cleland JGF, Coats AJS, Falk V, Gonzalez-Juanatey JR, Harjola VP, Jankowska EA, Jessup M, Linde C, Nihoyannopoulos P, Parissis JT, Pieske B, Riley JP, Rosano GMC, Ruilope LM, Ruschitzka F, Rutten FH, van der Meer P; ESC Scientific Document Group. 2016 ESC Guidelines for the diagnosis and treatment of acute and chronic heart failure: The Task Force for the diagnosis and treatment of acute and chronic heart failure of the European Society of Cardiology (ESC)Developed with the special contribution of the Heart Failure Association (HFA) of the ESC. Eur Heart J. 2016 Jul 14;37(27):2129-2200. doi: 10.1093/eurheartj/ehw128. Epub 2016 May 20. No abstract available.
PubMed 27206819Shigemitsu M, Nishio K, Kusuyama T, Itoh S, Konno N, Katagiri T. Nocturnal oxygen therapy prevents progress of congestive heart failure with central sleep apnea. Int J Cardiol. 2007 Feb 14;115(3):354-60. doi: 10.1016/j.ijcard.2006.03.018. Epub 2006 Jun 23.
PubMed 16806535du Bois RM, Weycker D, Albera C, Bradford WZ, Costabel U, Kartashov A, King TE Jr, Lancaster L, Noble PW, Sahn SA, Thomeer M, Valeyre D, Wells AU. Forced vital capacity in patients with idiopathic pulmonary fibrosis: test properties and minimal clinically important difference. Am J Respir Crit Care Med. 2011 Dec 15;184(12):1382-9. doi: 10.1164/rccm.201105-0840OC. Epub 2011 Sep 22.
PubMed 21940789Yi H, Shin K, Shin C. Development of the sleep quality scale. J Sleep Res. 2006 Sep;15(3):309-16. doi: 10.1111/j.1365-2869.2006.00544.x.
PubMed 16911033
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Oxygen Therapy on Readmissions of Patients With Chronic Heart Failure With Reduced Ejection Fraction
- ClinicalTrials.gov ID
- NCT05913739
- Acronym / sponsor ID
- ROXIC / ROXIC
- Conditions
- Chronic Heart Failure, Oxygen Deficiency
- Keywords
- oxygen therapy
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Difficulty in recruitment
- Enrolment
- 1 participants (actual)
- Lead sponsor
- Institut d'Investigació Biomèdica de Girona Dr. Josep TruetaUniversity, hospital or other
- Study start
- 1 Jul 2022 (actual)
- Primary completion
- 31 Jul 2024 (actual)
- Study completion
- 31 Jul 2024 (actual)
- First posted
- 22 Jun 2023 (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.
The purpose of this study is to assess patients with chronic heart failure and moderate-severe ventricular dysfunction (left ventricular ejection fraction (FEVE) <40%) with nocturnal desaturation (mean Oxygen saturation (SatO2) <90% and/or Cummulative time (TC) <90% > 22 minutes) without underlying respiratory disease, oxygen treatment during hours of night rest will reduce exacerbations, improve the ability to effort, sleep quality and poor prognostic parameters of heart failure, compared to patients not receiving oxygen treatment.
Detailed description
36 patients will attend at baseline, monthly, 3-month and 6-monthly visits.
BASELINE VISIT After being informed about the study and potential risks, all patients giving written informed consent, will be randomized (according to the list) receiving oxygen therapy (treatment group) and those not receiving this treatment (control group).
The following information will be collected:
- Demographics, pathological history, concomitant medication.
- Physical examination, vital signs (pressure, heart rate, weight)
- Doppler echocardiography (an echocardiography performed in the last 6 months will be accepted)
- Analytical determination of biomarkers NT-proBNP and ultrasensitive troponin.
- Assessment of baseline functional class by NYHA classification.
- Respiratory function tests: spirometry and diffusion (will accept tests performed in the last 6 months).
- Arterial blood gases.
- Nocturnal respiratory polygraphy.
- Exercise capacity with the 6-minute walk test (P6MM)
- Evaluation of health-related quality of life with the Minnesota questionnaire
- Assessment of sleep quality using the Pittsburgh questionnaire
If the patient belongs to the treatment group, the intervention will begin with oxygen therapy with a static concentrator and nasal cannula during the night at home, with a minimum compliance of six hours, following the usual clinical practice. Overnight pulse oximetry at home with oxygen will be performed to confirm if the prescribed flow rate is adequate to achieve a mean SatO2 >90% and/or that the correction of the CT90. If this is not achieved, it will be repeated, modifying the oxygen flow until the target is reached.
The control group will not undergo this intervention.
The rest of the medical treatment will be carried out according to the usual protocol of the Heart Failure Unit.
Follow up visits:
Clinical follow-up will be done at one month, three months and six months after the start of the intervention in the Chronic Respiratory Pathology Unit of Pneumology.
At 1 and 3 months
- Analytical determination of biomarkers nt-proBNP and ultrasensitive troponin (TnThs).
- Baseline functional class will be collected by New York Heart Association (NYHA) classification.
- Physical examination, vital signs (blood pressure (BP), Heart rate (HR), weight).
- Adverse effects and concomitant medication.
At 6 months
- Analytical determination of biomarkers nt-proBNP and ultrasensitive troponin (TnThs).
- Baseline functional class by NYHA classification will be collected.
- Physical examination, vital signs (BP, HR, weight).
- Evaluation of exercise capacity will be done by means of the 6-minute walk test (PM6M).
- Nocturnal pulse oximetry of control: treatment group with oxygen to evaluate the response and control group without oxygen to evaluate the evolution.
- Assessment of health-related quality of life with the Minnesota questionnaire.
- Sleep quality will be assessed using the Pittsburgh questionnaire.
- Adverse effects and concomitant medication.
In the follow-up periods (1, 3 and 6 months), the number of decompensations will be recorded:
- Hospitalizations for heart failure.
- Emergency care for heart failure requiring at least one dose of intravenous diuretic treatment.
- Need for outpatient intravenous depletive treatment due to the presence of congestive signs.
The study will be considered completed after 6 months of follow-up.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- A randomization of the patients will be carried out receiving oxygen therapy (treatment group) and those not receiving this treatment (control group): randomization will be done according to list
| Arm | Type | Receives |
|---|---|---|
| Oxygen Therapy | Active comparator | Other: Oxygen TherapyParticipants received nocturnal oxygen therapy (minimum 6 hours) for 6 months. |
| No Oxygen Therapy | No intervention | –Participants will not received oxygen therapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients > 18 years old.
- Diagnosis and clinic of chronic heart failure with ventricular dysfunction with left ventricular ejection fraction (LVEF) <40% under optimal medical treatment regardless of its etiology and having presented at least one episode of decompensation (visits to the emergency room, hospitalizations and/or need for intravenous depletive treatment) during the last year.
- Nocturnal desaturation defined as mean SatO2 <90% and/or Cummulative time (TC) <90>22 minutes to nocturnal pulse oximetry done at home.
- Signed informed consent
Key exclusion criteria (6 listed)
- Chronic lung disease (includes chronic obstructive pulmonary disease with Pulmonary respiratory function (PRF) (forced expiratory volume at one second/forced vital capacity (FEV1/FVC) <70%), diffuse interstitial diseases, pulmonary hypertension of respiratory).
- Obstructive sleep apnea-hypopnea syndrome (OSAHS) with Apnea hypopnea index (AHI) > 14.9.
- Previous treatment with oxygen therapy.
- Not agreeing to attend periodic cardiology visits.
- Being part of other clinical studies that contraindicate an intervention.
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 |
|---|---|---|
| Oxygen TherapyNocturnal oxygen therapy minimum 6 hours | Other | Oxygen Therapy |
Primary outcome
Nocturnal oxygen therapy at home in patients with heart failure heart rate and nocturnal desaturation can reduce the number of heart failure decompensations cardiac arrest.
Time frame: changes from baseline to 6th month
To assess whether treatment with nocturnal oxygen therapy at home in patients with heart failure heart rate and nocturnal desaturation (mean SatO2 <90% and/or CT <90%>22 minutes) no AOS manages to reduce the number of heart failure decompensations cardiac arrest (hospitalizations, visits to the emergency room or the need for depletive treatment intravenously) compared with patients not receiving oxygen therapy.
4 secondary outcomes
Oxygen during the night rest is accompanied by reduction of the biomarker NTproBNP (pg/mL). Oxygen during the night rest is accompanied by reduction the biomarker TnThs (pg/mL).
Time frame: changes from baseline to 6th month
Nocturnal oxygen therapy on symptoms using the class function of the NYHA, in the capacity of effort (P6MM).
Time frame: changes from baseline to 6th month
Nocturnal oxygen therapy on symptoms using the class function of the NYHA, in the quality of life (Minnesota score)
Time frame: changes from baseline to 6th month
Nocturnal oxygen therapy on symptoms using the class function of the NYHA, in the quality of the dream (pittsburg score).
Time frame: changes from baseline to 6th month
Results and safety
The study was stopped early (reason given: Difficulty in recruitment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2024.
- Background: PubMed 27234869Bekfani T, Abraham WT. Current and future developments in the field of central sleep apnoea. Europace. 2016 Aug;18(8):1123-34. doi: 10.1093/europace/euv435. Epub 2016 May 26.
- Background: PubMed 26612581Oldenburg O, Wellmann B, Buchholz A, Bitter T, Fox H, Thiem U, Horstkotte D, Wegscheider K. Nocturnal hypoxaemia is associated with increased mortality in stable heart failure patients. Eur Heart J. 2016 Jun 1;37(21):1695-703. doi: 10.1093/eurheartj/ehv624. Epub 2015 Nov 26.
- Background: PubMed 25636743Khayat R, Jarjoura D, Porter K, Sow A, Wannemacher J, Dohar R, Pleister A, Abraham WT. Sleep disordered breathing and post-discharge mortality in patients with acute heart failure. Eur Heart J. 2015 Jun 14;36(23):1463-9. doi: 10.1093/eurheartj/ehu522. Epub 2015 Jan 29.
- Background: PubMed 27615064Watanabe E, Kiyono K, Matsui S, Somers VK, Sano K, Hayano J, Ichikawa T, Kawai M, Harada M, Ozaki Y. Prognostic Importance of Novel Oxygen Desaturation Metrics in Patients With Heart Failure and Central Sleep Apnea. J Card Fail. 2017 Feb;23(2):131-137. doi: 10.1016/j.cardfail.2016.09.004. Epub 2016 Sep 9.
- Background: PubMed 19850211Gottlieb JD, Schwartz AR, Marshall J, Ouyang P, Kern L, Shetty V, Trois M, Punjabi NM, Brown C, Najjar SS, Gottlieb SS. Hypoxia, not the frequency of sleep apnea, induces acute hemodynamic stress in patients with chronic heart failure. J Am Coll Cardiol. 2009 Oct 27;54(18):1706-12. doi: 10.1016/j.jacc.2009.08.016.
- Background: PubMed 16282177Bradley TD, Logan AG, Kimoff RJ, Series F, Morrison D, Ferguson K, Belenkie I, Pfeifer M, Fleetham J, Hanly P, Smilovitch M, Tomlinson G, Floras JS; CANPAP Investigators. Continuous positive airway pressure for central sleep apnea and heart failure. N Engl J Med. 2005 Nov 10;353(19):2025-33. doi: 10.1056/NEJMoa051001.
- Background: PubMed 26323938Cowie MR, Woehrle H, Wegscheider K, Angermann C, d'Ortho MP, Erdmann E, Levy P, Simonds AK, Somers VK, Zannad F, Teschler H. Adaptive Servo-Ventilation for Central Sleep Apnea in Systolic Heart Failure. N Engl J Med. 2015 Sep 17;373(12):1095-105. doi: 10.1056/NEJMoa1506459. Epub 2015 Sep 1.
- Background: PubMed 22730336Damy T, Margarit L, Noroc A, Bodez D, Guendouz S, Boyer L, Drouot X, Lamine A, Paulino A, Rappeneau S, Stoica MH, Dubois-Rande JL, Adnot S, Hittinger L, d'Ortho MP. Prognostic impact of sleep-disordered breathing and its treatment with nocturnal ventilation for chronic heart failure. Eur J Heart Fail. 2012 Sep;14(9):1009-19. doi: 10.1093/eurjhf/hfs085. Epub 2012 Jun 22.
- Background: PubMed 18250216Yumino D, Bradley TD. Central sleep apnea and Cheyne-Stokes respiration. Proc Am Thorac Soc. 2008 Feb 15;5(2):226-36. doi: 10.1513/pats.200708-129MG.
- Background: PubMed 1572442Levi-Valensi P, Weitzenblum E, Rida Z, Aubry P, Braghiroli A, Donner C, Aprill M, Zielinski J, Wurtemberger G. Sleep-related oxygen desaturation and daytime pulmonary haemodynamics in COPD patients. Eur Respir J. 1992 Mar;5(3):301-7.
- Background: PubMed 19122308Toyama T, Seki R, Kasama S, Isobe N, Sakurai S, Adachi H, Hoshizaki H, Oshima S, Taniguchi K. Effectiveness of nocturnal home oxygen therapy to improve exercise capacity, cardiac function and cardiac sympathetic nerve activity in patients with chronic heart failure and central sleep apnea. Circ J. 2009 Feb;73(2):299-304. doi: 10.1253/circj.cj-07-0297. Epub 2008 Dec 27.
- Background: PubMed 27206819Ponikowski P, Voors AA, Anker SD, Bueno H, Cleland JGF, Coats AJS, Falk V, Gonzalez-Juanatey JR, Harjola VP, Jankowska EA, Jessup M, Linde C, Nihoyannopoulos P, Parissis JT, Pieske B, Riley JP, Rosano GMC, Ruilope LM, Ruschitzka F, Rutten FH, van der Meer P; ESC Scientific Document Group. 2016 ESC Guidelines for the diagnosis and treatment of acute and chronic heart failure: The Task Force for the diagnosis and treatment of acute and chronic heart failure of the European Society of Cardiology (ESC)Developed with the special contribution of the Heart Failure Association (HFA) of the ESC. Eur Heart J. 2016 Jul 14;37(27):2129-2200. doi: 10.1093/eurheartj/ehw128. Epub 2016 May 20. No abstract available.
- Individual participant dataSharing planned: Yes. All individual participant data (IPD) collected data can be shared as long as it is for research collaboration
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Hypotension
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Oxygen Therapy in people with Chronic Heart Failure and Oxygen Deficiency, run by Institut d'Investigació Biomèdica de Girona Dr. Josep Trueta at 1 site in Spain.
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 4 inclusion and 6 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: stopped early, as of the sponsor's last update on 8 Oct 2024. 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 Spain. 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 was stopped early (reason given: Difficulty in recruitment). Results are not available in the source record.
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?
Nocturnal oxygen therapy at home in patients with heart failure heart rate and nocturnal desaturation can reduce the number of heart failure decompensations cardiac arrest. (time frame: changes from baseline to 6th month). 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 NCT05913739, which also lists 18 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 8 Oct 2024.